A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Status: | Active, not recruiting |
---|---|
Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/25/2018 |
Start Date: | September 2014 |
End Date: | September 2019 |
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in
revealing the depth of endometrial cancer invasion.
revealing the depth of endometrial cancer invasion.
All research participants will receive fluorescein injection through their existing
intravenous line during their operative procedure for endometrial cancer staging. This will
consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine
arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as
per routine care. The pathologist will open the uterus and evaluate the endometrium. He or
she will then cut into the myometrium in an area most suspicious for invasion. The cross
section of the myometrium and endometrium will be photographed while exposed to a Woods lamp.
The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The
cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the
depth of invasion of the cancer into the myometrium on the basis of its physical appearance
under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for
the intra-operative evaluation of endometrial cancer. This information routinely is provided
in order to determine if lymph node staging is necessary.
The area that was measured and photographed will then be prepared for a frozen section to
document depth of invasion. This is the standard procedure performed during an endometrial
staging. The depth of invasion on the frozen section will be recorded. This same area will
undergo histologic confirmation by permanent pathology to determine depth of invasion. The
frozen section is part of routine standard of care in evaluation of endometrial cancer.
intravenous line during their operative procedure for endometrial cancer staging. This will
consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine
arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as
per routine care. The pathologist will open the uterus and evaluate the endometrium. He or
she will then cut into the myometrium in an area most suspicious for invasion. The cross
section of the myometrium and endometrium will be photographed while exposed to a Woods lamp.
The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The
cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the
depth of invasion of the cancer into the myometrium on the basis of its physical appearance
under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for
the intra-operative evaluation of endometrial cancer. This information routinely is provided
in order to determine if lymph node staging is necessary.
The area that was measured and photographed will then be prepared for a frozen section to
document depth of invasion. This is the standard procedure performed during an endometrial
staging. The depth of invasion on the frozen section will be recorded. This same area will
undergo histologic confirmation by permanent pathology to determine depth of invasion. The
frozen section is part of routine standard of care in evaluation of endometrial cancer.
Inclusion Criteria:
- Documented endometrial cancer and scheduled for hysterectomy as part of their
treatment.
- No known allergy to fluorescein dye
- Ability to understand and sign informed consent
- 18 years of age or older
Exclusion Criteria:
- Prior hysterectomy
- Known sensitivity to fluorescein dye
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-296-1099
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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